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510(k) K001806

REFRACTIVE SURGERY BLADES by Millennium Biomedical, Inc. — Product Code HNO

K001806 is an FDA 510(k) premarket notification submitted by Millennium Biomedical, Inc. for the device "REFRACTIVE SURGERY BLADES". The FDA issued a decision of Substantially Equivalent on September 12, 2000. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Millennium Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2000
Date Received
June 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Millennium Biomedical, Inc.

  • K041110 — MB 105 MILLENNIUM BLADES (October 13, 2004)
  • K011833 — MB 103 MILLENNIUM BLADES (February 15, 2002)
  • K020122 — MB 102 MILLENNIUM BLADES (February 15, 2002)
  • K003143 — MILLENNIUM BLADES, MODEL MB101 (December 11, 2000)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K172994 — EPI K Console (October 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)

FDA data resources